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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04911751




Registration number
NCT04911751
Ethics application status
Date submitted
9/05/2021
Date registered
3/06/2021

Titles & IDs
Public title
A Study to Investigate Efficacy and Safety of KBL697 in Patients with Moderate Plaque Type Psoriasis
Scientific title
A Phase 2, Double-Blind, Randomized, Placebo-Controlled, Study to Evaluate the Efficacy and Safety of KBL697 in Patients with Moderate Plaque Type Psoriasis
Secondary ID [1] 0 0
KBL-CURE-2020-02
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Psoriatic Plaque 0 0
Condition category
Condition code
Skin 0 0 0 0
Dermatological conditions
Skin 0 0 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - KBL697
Treatment: Drugs - KBL697

Experimental: Low dose group - 39 subjects for low dose group. 26 subjects on KBL697, 13 subjects on placebo.

Experimental: High dose group - 39 subjects for high dose group. 26 subjects on KBL697, 13 subjects on placebo.


Treatment: Drugs: KBL697
1 capsule BID of KBL697 or Placebo

Treatment: Drugs: KBL697
5 capsules BID of KBL697 or Placebo
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Psoriasis Area and Severity Index (PASI)
Timepoint [1] 0 0
Baseline to Week 12
Secondary outcome [1] 0 0
Psoriasis Area and Severity Index (PASI)
Timepoint [1] 0 0
Baseline to Weeks 2, 4 and 8
Secondary outcome [2] 0 0
Psoriasis Area and Severity Index (PASI) -50
Timepoint [2] 0 0
Baseline to Week 12
Secondary outcome [3] 0 0
Psoriasis Area and Severity Index (PASI) -75
Timepoint [3] 0 0
Baseline to Week 12
Secondary outcome [4] 0 0
Physician's Global Assessment (PGA)
Timepoint [4] 0 0
Baseline to Weeks 4, 8 and 12
Secondary outcome [5] 0 0
Physician's Global Assessment (PGA)
Timepoint [5] 0 0
Week 12
Secondary outcome [6] 0 0
Psoriasis-Affected Body Surface Area (BSA)
Timepoint [6] 0 0
Baseline to Weeks 4, 8 and 12
Secondary outcome [7] 0 0
Safety measure through incidence of treatment-emergent adverse events (TEAEs)
Timepoint [7] 0 0
Baseline to Week 16

Eligibility
Key inclusion criteria
* Male or female, aged 18 to 75 years (inclusive)
* Have a diagnosis of plaque type psoriasis for = 6 months
* Must have chronic plaque type psoriasis of moderate severity
* All subjects must agree and commit to the use of a reliable contraceptive regimen.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Current diagnosis of forms of psoriasis other than chronic plaque type only
* Drug-induced psoriasis
* Other inflammatory skin disease that may confound the evaluation of plaque psoriasis
* Failed 2 or more systemic treatments for plaque psoriasis
* Medicinal shampoos that contain tar and/or salicylic acid within 2 weeks prior to Baseline Visit

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
8/11/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
7/10/2024
Sample size
Target
Accrual to date
Final
80
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Premier Specialist - Kogarah
Recruitment hospital [2] 0 0
Westmead Hospital - Westmead
Recruitment hospital [3] 0 0
Veracity Clinical Trials Ltd - Woolloongabba
Recruitment hospital [4] 0 0
Sinclair Dermatology - East Melbourne
Recruitment postcode(s) [1] 0 0
2217 - Kogarah
Recruitment postcode(s) [2] 0 0
2145 - Westmead
Recruitment postcode(s) [3] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [4] 0 0
3002 - East Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Louisiana

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
KoBioLabs
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Ira Thorla
Address 0 0
Louisiana Dermatology Associates
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04911751